野战环境对Roche Cobas E411电化学发光免疫分析仪性能的影响

Influence of Roche Cobas E411performance under field environment

目的 探讨野战环境对Roche CCobas E411电化学发光免疫分析仪性能的影响。方法 对Roche Cobas E411系统的降钙素原（PCT）、N末端脑钠肽前体（NT-pro BNP）、肌红蛋白（Mb）、高敏肌钙蛋白T（hs TNT）4个项目在野战环境下进行精密度、正确度、回收率、线性评价,并与Roche Cobas E601电化学发光分析仪测定进行比较。结果 该仪器测定PCT的低、高水平批内变异系数（CV）分别为1.70%、0.70%,批间CV为4.09%、3.35%;NT-pro BNP的批内CV为2.46%、1.61%,批间CV为5.10%、2.59%;Mb的批内CV为2.42%、1.17%,批间CV为4.71%、2.51%;hs TNT的批内CV为2.83%、1.79%,批间CV为4.77%、3.14%。Roche Cobas E411与Roche Cobas E601电化学发光分析仪测定PCT、NT-pro BNP、Mb、hs TNT的结果均显著相关（r〉0.975,P〉0.05）,各项目回收率均在97%~103%。Roche Cobas E411测定PCT、NT-pro BNP、Mb、hs TNT的线性范围分别为（0.08~98.75）ng/m L、（7.95~33815.65）pg/m L、（26.94~2816.40）ng/m L、（5.23~9311.05）ng/L。结论 Roche Cobas E411检测PCT、NT-pro BNP、Mb、hs TNT具有优异的准确性、良好的精密度和较宽的线性范围,可满足野战环境需求。

Objective To explore the influence of Roche Cobas E411 electrochemistry luminescence immunity analyzer （Roche Cobas E411） performance under field environment. Methods Procalcitonin （ PCT）, N-terminal pro-B-type natriuretic peptide （NT-proBNP）, myoglobin （Mb） and high sensitive cardiac troponin T （hsTNT） detected by Roche Cobas E411 system were evaluated in precision, accuracy, recovery and linearity under field environment. The data was compared with Roche Cobas E601. Results The within-run coefficient of variations （ CVs） of PCT with low and high level control using Roche Cobas E 411 analyzer were 1.70%, 0.70% respectively, whereas the between-day CVs of PCT were 4. 09%, 3. 35%; the within-run CVs of NT-proBNP were 2.46%, 1.61%, which showed the between-day CVs of NT-proBNP were 5. 10%, 2. 59%; the within-run CVs of Mb were 2. 42%, 1.17%, meanwhile the between-day CVs of Mb were 4.71%, 2.51%;and the within-run CVs of hsTNT were 2.83%, 1.79%, whereas the between-day CVs of hsTNT were 4.77%, 3.14%. The level of PCT, NT-proBNP, Mb and hsTNT with Roche Cobas E411 analyzer were well related to the results on Roche Cobas E601 （ r〉0.975, P〉0.05） , and the recovery of these four items were all between 97%and 103%. The linear range of PCT, NT-proBNP, Mb and hsTNT were （0.08-98.75） ng/mL, （7.95-33815.65） pg/mL, （26.94-2816.40） ng/mL and （5.23-9311.05） ng/L respectively. Conclusion Roche Cobas E411 analyzer presents good accuracy, out-standing precision and wide analytical measurement range, which can meet the requirement of field environment.